Inflammatory Bowel DiseaseMBC-IBDNCT07210580
Testing the Impact of Measurement-Based Care on Quality of Life and Disease Management Among Veterans With Inflammatory Bowel Disease
A study testing MBC-IBD Intervention and Enhanced Treatment as Usual (E-TAU) in people with Inflammatory Bowel Disease, run by VA Office of Research and Development at 4 sites in United States.
Trial summary
This research study is addressing issues related to Inflammatory bowel disease (IBD), which is a chronic autoimmune disorder that affects over 60,000 Veterans. With close monitoring and timely treatment adjustment, the investigators can stop the natural progression of IBD, improving health-related quality of life… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Disease
- What is being tested?
- MBC-IBD Intervention and Enhanced Treatment as Usual (E-TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 4 sitesUnited States
- Study dates
- 9 Mar 2026to 30 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- receiving IBD care at one of the four sites
- reporting an impaired IBD-specific HRQOL using the Short IBD Questionnaire (SIBDQ<60, as used by others)
- willingness and ability to participate in study procedures
- Clinic staff criteria:
- relevant clinic staff (gastroenterologists, advanced practice providers, nurses) involved in MBC in IBD at the four study sites (Ann Arbor, Atlanta, Houston, Portland).
Who cannot join
- Veteran Patient Exclusion criteria:
- Presence of an ostomy or ileal-pouch anal anastomosis
- Severe comorbid medical condition that can confound PRO scores and treatment priorities (e.g., cancer, transplant).
- Exclusions can be readily determined from chart review and a baseline patient assessment
- Clinic staff exclusion criteria:
- Clinic staff without any experience with MBC in IBD.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105-2303
Shirley Cohen-Mekelburg, MD MS, (734) 845-5082, Shirley.Cohen-Mekelburg@va.gov
Nicolle Marinec, MPH, (734) 845-3653, Nicolle.Marinec@va.gov
- Not yet recruiting
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, 30033-4004
Meena A Prasad, MD, 404-321-6111 ext. 204091, meena.prasad@va.gov
Deirdre Dixon, AA, (404) 321-6111 ext. 20606, Deirdre.Dixon@va.gov
- Not yet recruiting
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030-4211
Jason Hou, MD, 713-794-7080, Jason.Hou@va.gov
Caroline Lugo, MS, (832) 205-6423, Caroline.Lugo@va.gov
- Not yet recruiting
VA Portland Health Care System, Portland, OR
Portland, Oregon, 97207-2964
Caitlin C Citti, MD, 503-220-8262 ext. 57497, caitlin.citti@va.gov
Stephanie J Unger, MSc BS, (503) 220-8262 ext. 57278, stephanie.unger@va.gov
About this study
Official title: Testing the Impact of Measurement-Based Care on Quality of Life and Disease Management Among Veterans With Inflammatory Bowel Disease: A Hybrid Effectiveness-Implementation Study
This research study is addressing issues related to Inflammatory bowel disease (IBD), which is a chronic autoimmune disorder that affects over 60,000 Veterans. With close monitoring and timely treatment adjustment, the investigators can stop the natural progression of IBD, improving health-related quality of life (HRQOL) and reducing flares and hospitalizations. However, it is difficult to closely monitor Veterans with IBD between clinic visits. There is a critical need for solutions that support close between visit monitoring of Veterans with IBD. The Measurement-Based Care (MBC) for IBD study will take a systematic approach to collect, share, and act on patient reported outcome (PRO) data that can be used to achieve close monitoring. MBC supports patients' in managing their condition and boosting their confidence in their ability to handle their symptoms and disease, and also supports care teams in early recognition of health issues. The investigators will work with both Veterans and their care teams to understand and assess this program so it can be a model for future initiatives.
Read the detailed description
Inflammatory bowel disease (IBD) is a chronic autoimmune disorder that affects over 60,000 Veterans and leads to highly symptomatic flares and complications. Close monitoring and timely treatment adjustment can stop the natural progression of IBD, improving health-related quality of life (HRQOL) and reducing flares and hospitalizations. However, it is difficult to closely monitor Veterans with IBD between clinic visits. There is a critical need for systematic solutions to support close between visit monitoring of Veterans with IBD without which they will continue to experience preventable impairment and disability. Measurement-based care (MBC) is a systematic approach to collect, share, and act on patient reported outcome (PRO) data that can be used to achieve close monitoring. MBC works by facilitating early recognition of clinical deterioration and timely clinician-driven treatment adjustment. MBC also increases patients' self-efficacy, their confidence in their ability to handle their symptoms and disease.
This project will use a Hybrid Type 1 effectiveness-implementation randomized trial design (n=250 Veterans with IBD) to test the effectiveness of MBC in IBD versus enhanced treatment as usual (E-TAU) on HRQOL and IBD-related events over 12-months and identify barriers and facilitators to MBC in IBD to inform its implementation in practice. The hypothesis is that at 12-month follow-up, Veterans randomized to MBC will have greater improvement in HRQOL and fewer IBD-related events (composite of flares, emergency department visits, hospitalization, surgery) than E-TAU. The primary objective is to test the effectiveness of MBC vs. E-TAU on key patient outcomes: IBD-specific patient reported HRQOL (primary outcome) and IBD-related events obtained via electronic health record data (secondary outcome). The secondary objective is to assess determinants of MBC in IBD implementation and acceptability with process evaluation.
- Conditions
- Inflammatory Bowel Disease
- Being tested
- MBC-IBD Intervention, Enhanced Treatment as Usual (E-TAU)
- Keywords
- Measurement Based Care, Inflammatory Bowel Disease
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBC-IBD InterventionBehavioural
Measurement Based Care for Inflammatory Bowel Disease - Intervention group. Veteran participants who are randomized to 12-months of MBC-IBD will be enrolled for 12 months. They will each complete surveys at baseline, 6-months, and 12-months post-randomization. After baseline completion, participants will be asked to complete weekly surveys. These assessments require completion of self-report questionnaires (PROs) which will be completed by phone or electronically using VA REDCap. MBC in IBD will not replace but rather provide care continuity between clinic visits. Patients allocated to MBC in IBD will receive automated reminders to complete weekly questionnaires. Further, patients will receive quarterly reports of their PRO data trends.
Enhanced Treatment as Usual (E-TAU)Other
E-TAU will receive standard of care, including monitoring and treatment as directed at the discretion of their gastroenterologist. Participants will also receive educational videos and fact sheets on various IBD-specific topics.
| Study group | Role | What they receive |
|---|---|---|
| MBC-IBD | Experimental | Measurement Based Care for Inflammatory Bowel Disease - Intervention group. Veteran participants who are randomized to 12-months of MBC-IBD will be enrolled for 12 months. They will each complete surveys at baseline, 6-months, and 12-months post-randomization. These assessments require completion of self-report questionnaires which will be completed by phone or electronically using VA REDCap. MBC in IBD will not replace but rather provide care continuity between clinic visits. Patients allocated to MBC in IBD will receive automated reminders to complete weekly questionnaires. Receives: Behavioral: MBC-IBD Intervention |
| E-TAU | Active comparator | Enhanced Treatment as Usual (E-TAU). Participants assigned to E-TAU will receive standard of care, including monitoring and treatment as directed at the discretion of their gastroenterologist. Standard of care is based on current evidence-based professional guidelines, including routine inflammatory biomarker assessments (e.g., annual fecal calprotectin), therapy plans, scheduled and as-needed clinic visits, and scheduled and as-needed telephone calls. Participants will also receive educational videos and fact sheets on various IBD-specific topics. Receives: Other: Enhanced Treatment as Usual (E-TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported Health-related Quality of Life
Test the effectiveness of MBC vs. E-TAU on key patient outcomes, specifically looking at IBD-specific patient reported HRQOL (primary outcome).
Assess IBD-specific HRQOL compared to E-TAU at 12-months follow-up. The investigators will first graphically explore the longitudinal data over time between the MBC and E-TAU groups. As the primary analytic model, the investigators will use an analysis of covariance (ANCOVA), fit using a linear regression model with SIBDQ score at 12 months as the dependent variable to estimate between-group differences in the primary endpoint. The model will include an indicator for treatment group (MBC vs. E-TAU) to estimate the 12-month treatment effect and adjust for baseline SIBDQ scores as a covariate and the stratification factors used for randomization (site, age, IBD type).
Measured: Baseline compared to 12 month follow-up.
Secondary outcomes (1)
IBD-related events
Review of IBD-related events obtained via electronic health record data: The investigators will first assess the total count of flares, emergency department visits, hospitalizations, and surgeries between baseline and 12 months and model cumulative composite outcomes at 12-months. If the total outcome counts are low (mostly 0's or 1's), the investigators will use a logistic regression model to model a dichotomized outcome. If the total counts have a range (e.g., 0 to 5 or more), the investigators will use a count data model such as Poisson or negative binomial regression model. The investigators will include intervention group (MBC vs. E-TAU) as the primary predictor, as well as study site, age, IBD type, and other covariates that show imbalances in baseline analyses.
Measured: Baseline compared to 12 month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start9 Mar 2026
- Primary completion29 Dec 2028 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Shirley Cohen-Mekelburg, MD MS, Principal investigator, VA Ann Arbor Healthcare System, Ann Arbor, MI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07210580
- Sponsor's protocol ID
- IIR 24-026
- Other IDs
- 824-MR-48366, 1845095
- Acronym
- MBC-IBD
- Status last verified
- Mar 2026
- First submitted
- 29 Sep 2025
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Impact of Measurement-Based Care on Quality of Life and Disease Management Among Veterans With Inflammatory Bowel Disease: A Hybrid Effectiveness-Implementation Study
- ClinicalTrials.gov ID
- NCT07210580
- Acronym / sponsor ID
- MBC-IBD / IIR 24-026
- Conditions
- Inflammatory Bowel Disease
- Keywords
- Measurement Based Care, Inflammatory Bowel Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 9 Mar 2026 (actual)
- Primary completion
- 29 Dec 2028 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 7 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is addressing issues related to Inflammatory bowel disease (IBD), which is a chronic autoimmune disorder that affects over 60,000 Veterans. With close monitoring and timely treatment adjustment, the investigators can stop the natural progression of IBD, improving health-related quality of life (HRQOL) and reducing flares and hospitalizations. However, it is difficult to closely monitor Veterans with IBD between clinic visits. There is a critical need for solutions that support close between visit monitoring of Veterans with IBD. The Measurement-Based Care (MBC) for IBD study will take a systematic approach to collect, share, and act on patient reported outcome (PRO) data that can be used to achieve close monitoring. MBC supports patients' in managing their condition and boosting their confidence in their ability to handle their symptoms and disease, and also supports care teams in early recognition of health issues. The investigators will work with both Veterans and their care teams to understand and assess this program so it can be a model for future initiatives.
Detailed description
Inflammatory bowel disease (IBD) is a chronic autoimmune disorder that affects over 60,000 Veterans and leads to highly symptomatic flares and complications. Close monitoring and timely treatment adjustment can stop the natural progression of IBD, improving health-related quality of life (HRQOL) and reducing flares and hospitalizations. However, it is difficult to closely monitor Veterans with IBD between clinic visits. There is a critical need for systematic solutions to support close between visit monitoring of Veterans with IBD without which they will continue to experience preventable impairment and disability. Measurement-based care (MBC) is a systematic approach to collect, share, and act on patient reported outcome (PRO) data that can be used to achieve close monitoring. MBC works by facilitating early recognition of clinical deterioration and timely clinician-driven treatment adjustment. MBC also increases patients' self-efficacy, their confidence in their ability to handle their symptoms and disease.
This project will use a Hybrid Type 1 effectiveness-implementation randomized trial design (n=250 Veterans with IBD) to test the effectiveness of MBC in IBD versus enhanced treatment as usual (E-TAU) on HRQOL and IBD-related events over 12-months and identify barriers and facilitators to MBC in IBD to inform its implementation in practice. The hypothesis is that at 12-month follow-up, Veterans randomized to MBC will have greater improvement in HRQOL and fewer IBD-related events (composite of flares, emergency department visits, hospitalization, surgery) than E-TAU. The primary objective is to test the effectiveness of MBC vs. E-TAU on key patient outcomes: IBD-specific patient reported HRQOL (primary outcome) and IBD-related events obtained via electronic health record data (secondary outcome). The secondary objective is to assess determinants of MBC in IBD implementation and acceptability with process evaluation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MBC-IBD | Experimental | Behavioral: MBC-IBD InterventionMeasurement Based Care for Inflammatory Bowel Disease - Intervention group. Veteran participants who are randomized to 12-months of MBC-IBD will be enrolled for 12 months. They will each complete surveys at baseline, 6-months, and 12-months post-randomization. These assessments require completion of self-report questionnaires which will be completed by phone or electronically using VA REDCap. MBC in IBD will not replace but rather provide care continuity between clinic visits. Patients allocated to MBC in IBD will receive automated reminders to complete weekly questionnaires. |
| E-TAU | Active comparator | Other: Enhanced Treatment as Usual (E-TAU)Enhanced Treatment as Usual (E-TAU). Participants assigned to E-TAU will receive standard of care, including monitoring and treatment as directed at the discretion of their gastroenterologist. Standard of care is based on current evidence-based professional guidelines, including routine inflammatory biomarker assessments (e.g., annual fecal calprotectin), therapy plans, scheduled and as-needed clinic visits, and scheduled and as-needed telephone calls. Participants will also receive educational videos and fact sheets on various IBD-specific topics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- receiving IBD care at one of the four sites
- reporting an impaired IBD-specific HRQOL using the Short IBD Questionnaire (SIBDQ<60, as used by others)
- willingness and ability to participate in study procedures
- relevant clinic staff (gastroenterologists, advanced practice providers, nurses) involved in MBC in IBD at the four study sites (Ann Arbor, Atlanta, Houston, Portland).
Key exclusion criteria (6 listed)
- Presence of an ostomy or ileal-pouch anal anastomosis
- Severe comorbid medical condition that can confound PRO scores and treatment priorities (e.g., cancer, transplant).
- Exclusions can be readily determined from chart review and a baseline patient assessment
- Clinic staff without any experience with MBC in IBD.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MBC-IBD InterventionMeasurement Based Care for Inflammatory Bowel Disease - Intervention group. Veteran participants who are randomized to 12-months of MBC-IBD will be enrolled for 12 months. They will each complete surveys at baseline, 6-months, and 12-months post-randomization. After baseline completion, participants will be asked to complete weekly surveys. These assessments require completion of self-report questionnaires (PROs) which will be completed by phone or electronically using VA REDCap. MBC in IBD will not replace but rather provide care continuity between clinic visits. Patients allocated to MBC in IBD will receive automated reminders to complete weekly questionnaires. Further, patients will receive quarterly reports of their PRO data trends. | Behavioural | MBC-IBD |
| Enhanced Treatment as Usual (E-TAU)E-TAU will receive standard of care, including monitoring and treatment as directed at the discretion of their gastroenterologist. Participants will also receive educational videos and fact sheets on various IBD-specific topics. | Other | E-TAU |
Primary outcome
Patient-reported Health-related Quality of Life
Time frame: Baseline compared to 12 month follow-up.
Test the effectiveness of MBC vs. E-TAU on key patient outcomes, specifically looking at IBD-specific patient reported HRQOL (primary outcome). Assess IBD-specific HRQOL compared to E-TAU at 12-months follow-up. The investigators will first graphically explore the longitudinal data over time between the MBC and E-TAU groups. As the primary analytic model, the investigators will use an analysis of covariance (ANCOVA), fit using a linear regression model with SIBDQ score at 12 months as the dependent variable to estimate between-group differences in the primary endpoint. The model will include an indicator for treatment group (MBC vs. E-TAU) to estimate the 12-month treatment effect and adjust for baseline SIBDQ scores as a covariate and the stratification factors used for randomization (site, age, IBD type).
1 secondary outcome
IBD-related events
Time frame: Baseline compared to 12 month follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shirley Cohen-Mekelburg, MD MS principal investigator
VA Ann Arbor Healthcare System, Ann Arbor, MI
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MBC-IBD Intervention and Enhanced Treatment as Usual (E-TAU) in people with Inflammatory Bowel Disease, run by VA Office of Research and Development at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shirley Cohen-Mekelburg, MD MS ((734) 845-5082, Shirley.Cohen-Mekelburg@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported Health-related Quality of Life (time frame: Baseline compared to 12 month follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.